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临床试验/NCT04922619
NCT04922619已完成不适用

Evaluation of the Impact of a Tonotopy Based Fitting on the Speech and Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

MED-EL Elektromedizinische Geräte GesmbH2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
speech recognition in noise

研究概览

简要总结

Main objective:

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.

Secondary objectives:

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test).

Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet.

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.

详细描述

Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain (Nimmons et al.).

A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes).

The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

The fitting software developed by the manufacturers proposed a default fitting with a lower limit between 100 and 250 Hz according to the brands and an upper limit of about 8500 Hz. The frequency bands assigned to each electrode follow a logarithmic scale with the high frequencies for the basal electrodes and the low frequencies for the apical electrodes. This distribution takes into account the number of active electrodes but does not take into account the anatomy and the natural cochlear tonotopy specific to each patient.

Several studies have analyzed the anatomical variations of the cochlear dimensions: size of the cochlea and the ratio between the contact surfaces of the electrodes with the cochlea are variable from one patient to another (Stakhovskaya O et al., P. Pelliccia et al.).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

Double blind study: the patient and the investigator don't know the fitting.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (>= 18 years old) speaking French
  • Patient who fulfils the criteria for cochlear implantation

排除标准

  • retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
  • patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz

结局指标

主要结局

speech recognition in noise

时间窗: at 12 weeks post-activation

The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

次要结局

  • speech recognition in quiet(at 12 weeks post-activation)
  • Qualitative measure of music(at 12 weeks post-activation)
  • Melodic contour test(at 12 weeks post-activation)

研究者

发起方
MED-EL Elektromedizinische Geräte GesmbH
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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